MAUDE Adverse Event Report: COOK IRELAND LTD COLON DECOMPRESSION SET; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Catalog Number CDSG-14-175

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k171619.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Nurse had a difficult time getting the inner guiding catheter out.They stated they could not get the black, soft stylet out.The staff used 2 different tubes and the same thing happened.It is a very seasoned nurse so i have all confidence she did everything right.The following has been requested- jm (b)(6) 2022, jm (b)(6) 2022.Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Did the patient require any additional procedures due to this occurrence? did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? the following has been requested- jm (b)(6) 2022, (b)(6) 2022.For all complaints, ask: was the device flushed before use? n/a, yes, no.What was flushed through the device (water, saline, etc.)? n/a, water, saline, other? if other please specify.Was lubrication applied to the decompression tube? n/a yes, no.Details of the wire guide used (diameter, type, make)? if not with the device in question, how was the procedure finished? please advise the anatomical location of the intended target site.How experienced was the physician with using the cdsg? did the patient require any additional procedures as a result of this event? n/a, yes, no.What intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.If yes, please specify what was observed and where on the device it was observed.What is the endoscope manufacturer and model number that was used? was resistance encountered when advancing the decompression tube into position? n/a, yes, no.If resistance was encountered, was the endoscope withdrawn a short distance? n/a, yes, no.How often was the decompression tube irrigated? did any section of the device detach inside the endoscope or patient? n/a, yes, no.How long was the set left in dwelling?.

Manufacturer Narrative

Pma/510(k) # k171619.Device evaluation: the cdsg-14-175 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review including ifu review: as the lot number of the complaint device is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution cdsg-14-175 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use, ifu0102-4, states the following: ¿visually inspect the packaging and device.If the packaging is opened or damaged when received, do not use.If a device abnormality is detected that would prohibit proper working condition, do not use." there is no evidence to suggest the user did not follow the ifu (ifu0102-4).Root cause review: a definitive root cause could not be determined as the device was not returned and due to limited information.A possible root cause could be attributed to difficult patient anatomy.It is possible that a difficult patient anatomy contributed to resistance during removal of the guiding catheter from the device.Several attempts have been made to request additional information but it has not been forthcoming, if this is received at a later date he investigation will be updated accordingly.Summary: the complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: COLON DECOMPRESSION SET
• Type of Device: FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13965943
• MDR Text Key: 298229127
• Report Number: 3001845648-2022-00193
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2022
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1